MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXZERO¿ MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	MZ5301
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd maxzero¿ multi-fuse pressure rated extension set with needleless connector leaked saline when removing the syringe.The following information was provided by the initial reporter: "the nurse have a luer slip syringe with saline, on a mz5301 and at the end of it she takes the syringe off, and there comes small stink of saline in her face and eyes.".
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: a mz5301 sample was not available for investigation; and details of the lot number were not provided.The feedback provided by the customer indicates that upon disconnection of an unknown luer slip syringe, the clinician experienced splashing of saline onto their face and eyes.The details of this feedback were forwarded to the manufacturing site for investigation.The lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.Without a sample a definitive root cause for the customer's experience could not be determined in this instance; however previous investigations have identified that if the connecting male luer is disconnected from the maxzero too quickly, it is possible for droplet separation of this nature to occur as any fluid droplets would be propelled due to the spring force of the piston.As a result of a small number of similar reports, bd has updated the directions for use (dfu) with the following recommendation related to disconnection of the device: ¿when disconnecting a luer-lock or luer-slip syringe or tubing set from the maxzero connector, carefully rotate the luer counter clockwise a 360-degree turn using a controlled motion, to minimize fluid escaping¿.A review of the customer feedback database indicates that this is an isolated feedback with no further reports of this nature against the mz5301 product in the past 12 months.

• Brand Name: BD MAXZERO¿ MULTI-FUSE PRESSURE RATED EXTENSION SET WITH NEEDLELESS CONNECTOR
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15581104
• Report Number: 9616066-2022-01511
• Device Sequence Number: 15039200
• Product Code: FPA
• UDI-Device Identifier: 10885403230547
• UDI-Public: (01)10885403230547
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MZ5301
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2022
• Initial Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown